FDA.reportPublic FDA data

Migun

Primary DI
B556HY7770
Brand
Migun
Company
MIGUN LIFE CO., LTD
Model
HY777
Device description
Provides infrared heat to different areas of the body. It is indicated for the temporary relief of minor muscle and joint pain. the temporary relief of joint pain associated with arthritis. muscle spasms, minor sprains and strains, minor muscular back pain, muscle relaxation therapy and temporary increase of circulation where applied.
Published
2017-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041200000THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000Migun Medical Instrument Co. , Ltd.2004-06-17JFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B556HY7770PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689266158
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B556ED3010MigunED3012017-05-01
B556HY7000U0MigunHY7000U2017-05-01
B556HY7000UM0MigunHY7000UM2017-05-01
B556MG31000MigunMG31002017-05-01
B556MG33000MigunMG33002017-05-01
B556MG36000MigunMG36002017-05-01

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Primary DI, Brand, Company table
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